drugset / Trial / NCT07460986

A Phase Ib/II Study to Evaluate Safety and Efficacy of Bexmarilimab in Combination With Doxorubicin in Metastatic Soft-tissue Sarcoma.

NCT07460986 ↗

Phase 1/2 Recruiting 278 enrolled MedSIR Faron Pharmaceuticals Ltd · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial will Study a type of sarcoma defined metastatic soft-tissue sarcoma (STS). Participants will be treated with bexmarilimab, a CLEVER-1 antibody plus doxorubicin, a chemotherapy. The main purpose of the Study is to analyze the safety (to find out how safe or toxic a treatment is to appropriately manage the risks) and efficacy (to find out how effective a treatment is) of bexmarilimab combined with doxorubicin in participants who have STS.

Timeline

Start
2026-08-20
Primary completion
2028-07
Completion
2028-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin Other / unclassified 75 mg/m2 Intravenous
Subject bexmarilimab Monoclonal antibody 1 mg/kg Intravenous
Subject bexmarilimab Monoclonal antibody 3 mg/kg Intravenous
Subject bexmarilimab Monoclonal antibody 6 mg/kg Intravenous

Indications